DepressionCOMETNCT02567266

Community Study of Outcome Monitoring for Emotional Disorders in Teens

A study testing Unified Protocol for Adolescents (UP-A), Youth Outcomes Questionnaire and Treatment as Usual in people with Depression and Anxiety, run by University of Miami at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is being done to compare three types of talk therapies for youth who struggle with emotional and behavioral problems (e.g., anxiety, sadness, worries) in Community Mental Health Clinics in Connecticut (CT) and Florida (FL). Read more about this study

Who is it for?: Ages 12 to 18 years
Conditions the study is for: Depression, Anxiety
What is being tested?: Unified Protocol for Adolescents (UP-A), Youth Outcomes Questionnaire and Treatment as Usual
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 2 sitesUnited States
Study dates: Jan 2016to 30 Jul 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Male or female adolescents between the ages of 12-18 years at the time of enrollment with clinically significant symptoms of anxiety or depression at baseline. Evidence of clinically significant symptoms will be defined as a Clinical Severity Rating (CSR) greater than or equal to 4 on any DSM-5 defined anxiety disorder (e.g., generalized anxiety disorder, social phobia, selective mutism, separation anxiety disorder) or depressive disorder (e.g., major depressive disorder, persistent depressive disorder), or an adjustment disorder with depressed mood, anxiety, or mixed anxiety and depressed mood.
The adolescent is determined by the community mental health center to be eligible for outpatient psychosocial services at the clinic and determined by the study IE to be appropriate for outpatient psychosocial intervention (e.g., no major cognitive impairment or active suicidality) based on clinical interview.
The adolescent lives (for at least 50% time) with legal guardian and this guardian is willing to attend treatment sessions and participate in study assessments (every effort will be made to encourage the same caregiver to participate in all assessments).
Adolescent and parent/guardian are able to complete all study procedures in English or Spanish.

Who cannot join

Adolescents will be excluded if they are receiving concurrent psychotherapy, family therapy or similar psychosocial interventions.
Consistent with the prior RCT of the UP-A, the use of psychopharmacologic treatments for anxiety or depression is allowable; but the adolescent must be on a stable dosage for 2 months for SSRI or 1 month for benzodiazepine prior to consenting to the study. The type, dosage and frequency of medication will be monitored at all major study assessment points, but subsequent changes will not incur exclusion from the investigation. Adolescents on stable doses of a stimulant for ADHD for at least one month or on a SNRI (e.g., Strattera) for ADHD for at least two months can also be included.
Adolescents who are currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded and referred for appropriate clinical intervention.
Adolescents with a current substance abuse disorder as determined using the ADIS-5-C/P, will be excluded.
Consistent with prior trials of the UP-A, youth with primary conditions not specified for exclusion (e.g., eating disorders, schizophrenia) will be screened. As long as study staff concur that an emotional disorder treatment focus is appropriate, these youth will be included.
Adolescents with a reported history of intellectual disability or for whom there is substantial evidence (e.g., multiple learning disorders, extensive school-based accommodations for learning) that the cognitive level of the UP-A would make it inappropriate as an individual therapy modality, as determined via Family Background Questionnaire and/or based on PI judgement, will be excluded.
Given additional complexities obtaining informed consent, adolescents who are currently placed in the foster care system will be excluded.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Miami
Coral Gables, Florida, 33124
University of Connecticut Health Center
West Hartford, Connecticut, 06119

Other trials in United States

About this study

Conditions: Depression, Anxiety
Being tested: Unified Protocol for Adolescents (UP-A), Youth Outcomes Questionnaire, Treatment as Usual
Medical subject headings: Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Unified Protocol for Adolescents (UP-A)Behavioural
The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. It is a developmental adaptation of the Unified Protocol, a transdiagnostic treatment for adults with emotional disorders. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.
Youth Outcomes QuestionnaireBehavioural
The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging "critical items" that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived "alerts" when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.
Treatment as UsualBehavioural
Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.

Study groups in NCT02567266
Study group	Role	What they receive
Unified Protocol for Adolescents (UP-A)	Experimental	Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence. Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system. Receives: Behavioral: Unified Protocol for Adolescents (UP-A); Behavioral: Youth Outcomes Questionnaire
Treatment as Usual Plus (TAU+)	Experimental	Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual Receives: Behavioral: Youth Outcomes Questionnaire; Behavioral: Treatment as Usual
Treatment as Usual (TAU)	Active comparator	Participants will receive Treatment as Usual provided at the study clinics. Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Global Impression - Improvement (CGI-I) Scores
This is a independent evaluator rated measure of improvement in symptoms and functioning. The CGI-I has a total range from 1-7 with the lower scores indicating more improvement in functioning.
Measured: At 16 weeks, at 28 weeks.

Secondary outcomes (2)

Clinical Global Impression - Severity (CGI-S) Scores
This is a independent evaluator rated measure of severity of symptoms. The CGI-S has a total range from 1-7 with the higher scores indicating higher symptom severity.
Measured: At 16 weeks, at 28 weeks.
Children's Global Assessment Scale (CGAS) Scores
This is a independent evaluator rated measure of global functional impairment.The GCAS has a total range from 1-100 with the higher scores indicating better functioning.
Measured: At 16 weeks, at 28 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201630 Jul 2020

First posted2 Oct 2015 (estimated)
Study startJan 2016
Primary completion30 Jul 2020
Study completion30 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02567266
Sponsor's protocol ID: 20150187
Other IDs: R01MH106536, R01MH064089
Acronym: COMET
Status last verified: Aug 2021
First submitted: 1 Oct 2015
Last updated: 18 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ehrenreich-May J, Jensen-Doss A, Milgram L, Rosenfield D, Shaw AM, LoCurto J, Nanda Robinson M, Caron EB, Lee P, Ginsburg GS. A randomized controlled effectiveness trial of transdiagnostic treatment and measurement-based care for adolescents with emotional disorders in community clinics. J Consult Clin Psychol. 2025 Mar;93(3):144-160. doi: 10.1037/ccp0000947.
PubMed 40014505
Casline E, Woodard GS, Lane E, Pollowitz S, Douglas S, Ehrenreich-May J, Ginsburg GS, Jensen-Doss A. Consultation Content and Techniques for measurement-Based Care Implementation in Youth Community Mental Health Settings. Adm Policy Ment Health. 2025 Mar;52(2):401-414. doi: 10.1007/s10488-024-01417-8. Epub 2024 Oct 13.
PubMed 39397117

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Community Study of Outcome Monitoring for Emotional Disorders in Teens
ClinicalTrials.gov ID: NCT02567266
Acronym / sponsor ID: COMET / 20150187
Conditions: Depression, Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: University of Connecticut, National Institute of Mental Health (NIMH)
Study start: Jan 2016
Primary completion: 30 Jul 2020 (actual)
Study completion: 30 Jul 2020 (actual)
First posted: 2 Oct 2015 (estimated)
Results: Posted 18 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Unified Protocol for Adolescents (UP-A)	Experimental	Behavioral: Unified Protocol for Adolescents (UP-A), Behavioral: Youth Outcomes QuestionnaireParticipants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence. Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system.
Treatment as Usual Plus (TAU+)	Experimental	Behavioral: Youth Outcomes Questionnaire, Behavioral: Treatment as UsualParticipants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual
Treatment as Usual (TAU)	Active comparator	Behavioral: Treatment as UsualParticipants will receive Treatment as Usual provided at the study clinics.

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Male or female adolescents between the ages of 12-18 years at the time of enrollment with clinically significant symptoms of anxiety or depression at baseline. Evidence of clinically significant symptoms will be defined as a Clinical Severity Rating (CSR) greater than or equal to 4 on any DSM-5 defined anxiety disorder (e.g., generalized anxiety disorder, social phobia, selective mutism, separation anxiety disorder) or depressive disorder (e.g., major depressive disorder, persistent depressive disorder), or an adjustment disorder with depressed mood, anxiety, or mixed anxiety and depressed mood.
The adolescent is determined by the community mental health center to be eligible for outpatient psychosocial services at the clinic and determined by the study IE to be appropriate for outpatient psychosocial intervention (e.g., no major cognitive impairment or active suicidality) based on clinical interview.
The adolescent lives (for at least 50% time) with legal guardian and this guardian is willing to attend treatment sessions and participate in study assessments (every effort will be made to encourage the same caregiver to participate in all assessments).
Adolescent and parent/guardian are able to complete all study procedures in English or Spanish.

Key exclusion criteria (7 listed)

Adolescents will be excluded if they are receiving concurrent psychotherapy, family therapy or similar psychosocial interventions.
Consistent with the prior RCT of the UP-A, the use of psychopharmacologic treatments for anxiety or depression is allowable; but the adolescent must be on a stable dosage for 2 months for SSRI or 1 month for benzodiazepine prior to consenting to the study. The type, dosage and frequency of medication will be monitored at all major study assessment points, but subsequent changes will not incur exclusion from the investigation. Adolescents on stable doses of a stimulant for ADHD for at least one month or on a SNRI (e.g., Strattera) for ADHD for at least two months can also be included.
Adolescents who are currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded and referred for appropriate clinical intervention.
Adolescents with a current substance abuse disorder as determined using the ADIS-5-C/P, will be excluded.
Consistent with prior trials of the UP-A, youth with primary conditions not specified for exclusion (e.g., eating disorders, schizophrenia) will be screened. As long as study staff concur that an emotional disorder treatment focus is appropriate, these youth will be included.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Unified Protocol for Adolescents (UP-A)The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. It is a developmental adaptation of the Unified Protocol, a transdiagnostic treatment for adults with emotional disorders. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.	Behavioural	Unified Protocol for Adolescents (UP-A)
Youth Outcomes QuestionnaireThe YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging "critical items" that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived "alerts" when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.	Behavioural	Treatment as Usual Plus (TAU+), Unified Protocol for Adolescents (UP-A)
Treatment as UsualClinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.	Behavioural	Treatment as Usual (TAU), Treatment as Usual Plus (TAU+)

Primary outcome

Clinical Global Impression - Improvement (CGI-I) Scores
Time frame: At 16 weeks, at 28 weeks.
This is a independent evaluator rated measure of improvement in symptoms and functioning. The CGI-I has a total range from 1-7 with the lower scores indicating more improvement in functioning.

2 secondary outcomes

Clinical Global Impression - Severity (CGI-S) Scores
Time frame: At 16 weeks, at 28 weeks.
Children's Global Assessment Scale (CGAS) Scores
Time frame: At 16 weeks, at 28 weeks.

Results and safety

Results posted to the registry on 18 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Unified Protocol for Adolescents (UP-A)	68	45
Treatment as Usual Plus (TAU+)	60	45
Treatment as Usual (TAU)	68	52

Primary outcome: Clinical Global Impression - Improvement (CGI-I) Scores

Time frame: At 16 weeks, at 28 weeks.. Mean (Standard Deviation). Unit: score on a scale

Measure	Unified Protocol for Adolescents (UP-A) n = 46	Treatment as Usual Plus (TAU+) n = 41	Treatment as Usual (TAU) n = 49
Post (16 weeks)	2.85 (.965)	3.20 (1.167)	3.02 (.878)
Follow-up (28 weeks)	2.47 (.894)	2.45 (.904)	2.76 (1.128)

Unified Protocol for Adolescents (UP-A) vs Treatment as Usual Plus (TAU+): Mean Difference (Net): -.19 (95% CI -.58 to .20), p = .338, Mixed Models Analysis
Treatment as Usual Plus (TAU+) vs Treatment as Usual (TAU): Mean Difference (Net): 0.16 (95% CI -0.24 to 0.57), p = 0.425, Mixed Models Analysis
Unified Protocol for Adolescents (UP-A) vs Treatment as Usual Plus (TAU+): Mean Difference (Net): -0.36 (95% CI -0.77 to 0.06), p = 0.09, Mixed Models Analysis

Population analysed: Not all participants were able to complete the CGI-I Questionnaire at Post Visit (16 Weeks) and at Follow Up Visit (28 weeks).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Unified Protocol for Adolescents (UP-A)	5 of 68 (7.4%)	0 of 68 (0%)	0 of 68
Treatment as Usual Plus (TAU+)	2 of 60 (3.3%)	0 of 60 (0%)	0 of 60
Treatment as Usual (TAU)	1 of 68 (1.5%)	0 of 68 (0%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40014505Ehrenreich-May J, Jensen-Doss A, Milgram L, Rosenfield D, Shaw AM, LoCurto J, Nanda Robinson M, Caron EB, Lee P, Ginsburg GS. A randomized controlled effectiveness trial of transdiagnostic treatment and measurement-based care for adolescents with emotional disorders in community clinics. J Consult Clin Psychol. 2025 Mar;93(3):144-160. doi: 10.1037/ccp0000947.
Derived from this study: PubMed 39397117Casline E, Woodard GS, Lane E, Pollowitz S, Douglas S, Ehrenreich-May J, Ginsburg GS, Jensen-Doss A. Consultation Content and Techniques for measurement-Based Care Implementation in Youth Community Mental Health Settings. Adm Policy Ment Health. 2025 Mar;52(2):401-414. doi: 10.1007/s10488-024-01417-8. Epub 2024 Oct 13.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Golda Ginsburg, Ph.D. principal investigator

University of Connecticut

Amanda Jensen-Doss, Ph.D. principal investigator

University of Miami

Jill Ehrenreich-May, Ph.D. principal investigator

University of Miami

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Global Impression - Improvement (CGI-I) Scores (time frame: At 16 weeks, at 28 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02567266, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.